Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol

This study has been completed.
Sponsor:
Collaborators:
Harvard School of Public Health
Centre for Infectious Disease Research in Zambia (CIDRZ)
University of Limpopo MEDUNSA
Health Systems Trust (HST)
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier:
NCT00639145
First received: March 14, 2008
Last updated: August 13, 2013
Last verified: August 2013

March 14, 2008
August 13, 2013
September 2010
December 2012   (final data collection date for primary outcome measure)
Number of Congenital birth defects [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00639145 on ClinicalTrials.gov Archive Site
Adverse Pregnancy outcomes [ Time Frame: At outcome of pregnancy ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol
Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus‐Infected Women Receiving Antiretroviral Therapy in Sub‐ Saharan Africa

The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated by HIV-positive pregnant women and their infants in South Africa and Zambia.

Although the use of HAART in pregnancy has significantly reduced rates of vertical transmission of HIV-1, some questions remain regarding the safety of these therapies and their potential impact on the uninfected infant.

The overall goal of the project is to establish a voluntary exposure-registry and perform observational surveillance on HIV - positive pregnant women who are exposed to antiretroviral products during the prenatal period, in order to evaluate the outcome of the pregnancy and safety of the products in HIV-positive pregnant women, and their infants.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

HIV positive pregnant women attending ART clinics

  • HIV Infections
  • HIV Positive
  • Pregnant Women
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV positive pregnant woman on antiretroviral treatment
  • Able and willing to participate and provide informed consent
  • Be at least 18 years of age or older than legal age to provide consent
  • If under legal age, must have legal guardian who is able to give consent
  • Be an emancipated minor

Exclusion Criteria:

  • History of mental illness
  • History of condition that would preclude provision of consent
  • Inability to provide consent
Female
15 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa,   Zambia
 
NCT00639145
EGPAF-001
No
Elizabeth Glaser Pediatric AIDS Foundation
Elizabeth Glaser Pediatric AIDS Foundation
  • Harvard School of Public Health
  • Centre for Infectious Disease Research in Zambia (CIDRZ)
  • University of Limpopo MEDUNSA
  • Health Systems Trust (HST)
Principal Investigator: Richard Marlink, MD Elizabeth Glaser Pediatric AIDS Foundation
Elizabeth Glaser Pediatric AIDS Foundation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP